Dosing, Administration
and Safety Information
LEUKINE is indicated for use following induction chemotherapy in older adults with acute
myeloid leukemia (AML) to shorten time to neutrophil recovery and to reduce the incidence
of severe and life-threatening infections and infections resulting in death.
LEUKINE® (sargramostim) Dosing and Administration
Recommended dosing for adults 55 years and older with AML following induction chemotherapy
Dosage
Initiate
Continue until
Adjust or interrupt
Discontinue
250 mcg/m2/day by intravenous infusion over a 4-hour period
4 days following completion of chemotherapy (approximately day 11)
ANC >1500 cells/mm3 is achieved for 3 consecutive days or a maximum of 42 days
If ANC >20,000 cells/mm3, reduce dose by half or interrupt treatment
If leukemic growth recurs
ANC=absolute neutrophil count.
Recommended doses of LEUKINE based on body surface area
Body Surface
Area (m2)
LEUKINE
Dose (mcg)
Liquid LEUKINE
(500 mcg/mL) Volume (mL)
Reconstituted Lyophilized LEUKINE
(250 mcg/mL) Volume (mL)
1.0 1.2 1.4 1.6 1.8 2.0 250 300 350 400 450 500 0.5 0.6 0.7 0.8 0.9 1.0 1.0
1.2
1.4
1.6
1.8
2.0
Liquid LEUKINE
• Supplied as a multiple-use vial
• Shipped via overnight delivery directly to you
– Cold packs maintain proper
refrigerated temperature
• Stored at 2-8°C (36-46°F)
– Once the vial has been entered, liquid LEUKINE
may be stored in the vial for up to 20 days at 2-8°C
– Discard any remaining solution after 20 days
LEUKINE is Also Available in a Lyophilized Formulation
• Lyophilized powder: 250 mcg in a single-use vial ready for sterile reconstitution
Drug Interactions
• Drugs that can increase white blood cells (WBCs), such as lithium and corticosteroids, should be used with caution while receiving
LEUKINE. Also, LEUKINE should not be used 24 hours before through 24 hours after any chemotherapy or radiation therapy. Interactions
between LEUKINE and other drugs have not been fully evaluated.
Important Safety Information for LEUKINE (sargramostim)
• Leukine is contraindicated in patients with excessive leukemic myeloid blasts in bone marrow or peripheral blood (≥10%);
in patients with known hypersensitivity to GM-CSF, yeast-derived products, or any component of Leukine; and for concomitant
use with chemotherapy and radiotherapy.
•Serious allergic or anaphylactic reactions have been reported with Leukine. If any serious allergic or anaphylactic reactions occur,
Leukine therapy should be immediately discontinued and appropriate therapy initiated.
•Liquid solutions containing benzyl alcohol (including liquid Leukine) or lyophilized Leukine reconstituted with Bacteriostatic Water
for Injection, USP (0.9% benzyl alcohol) should not be administered to neonates.
Please see additional Important Safety Information on next page
and full Prescribing Information available at www.leukine.com.
LEUKINE® (sargramostim) Safety Information
Adverse events occurring in >50% of AML patients taking LEUKINE‡
Adverse Events
Fever (no infection) Liver-associated events Skin-associated events Infection Nausea Metabolic-associated events Diarrhea LEUKINE
Placebo
81% 77% 77% 65% 58% 58% 52% 74%
83%
45%
68%
55%
49%
53%
Results of the pivotal study
of LEUKINE involving patients
aged 55 to 70 years with de
novo AML.
‡
Management of common LEUKINE adverse events1
Adverse Events Tips for Management
Systemic
Transient low-grade temp.
elevation (<100.5°F/38°C)
Bone pain Local (Subcutaneous)
Consider possibility of infection before treating with acetaminophen
Acetaminophen
Mild skin reaction
• Allow LEUKINE to come to room
• Apply ice to the site for
at injection site
temperature before injection 1 minute immediately prior
• Rotate injection sites
to and after injection
• Do not rub or pinch the skin
• Use the appropriate needle size
before or after injections (25-27G) and length (5/8”)
• Keep the drug volume small
• Inject slowly (30-60 seconds)
Important Safety Information for Leukine (sargramostim)
• Leukine should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates, or congestive
heart failure, respiratory symptoms or disease; cardiac symptoms or disease; and renal or hepatic dysfunction.
• Edema, capillary leak syndrome, pleural and/or pericardial effusion, sequestration of granulocytes in the pulmonary circulation,
and dyspnea have been reported in patients after Leukine administration. Occasional transient supraventricular arrhythmia has been
reported during Leukine administration. Leukine has induced the elevation of serum creatinine or bilirubin and hepatic enzymes in
some patients. Monitoring of renal and hepatic function in patients with preexisting renal or hepatic dysfunction is recommended at
least every other week during Leukine administration.
• Adverse events occurring in >10% of patients receiving Leukine in controlled clinical trials and reported in a higher frequency than
placebo were: in AML patients – (fever, skin reactions, metabolic disturbances, nausea, vomiting, weight-loss, edema, anorexia); in
Autologous BMT patients – (asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder); and in Allogeneic BMT patients –
(abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, GI hemorrhage, pruritus, bone pain, arthralgia,
eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increased creatinine, hypomagnesemia, edema, pharyngitis,
epistaxis, dyspnea, insomnia, anxiety, high BUN, and high cholesterol).
• If ANC > 20,000 cells/mm3 or if platelet counts > 500,000/mm3, Leukine administration should be interrupted
or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed.
Please
see
full prescribing
information
• Leukine
therapy
should be discontinued
if disease progression is detected during treatment.
available
at
www.leukine.com
•D
rugs that can increase WBCs, such as lithium and corticosteroids, should be used with caution while receiving
Leukine Interactions between Leukine and other drugs have not been fully evaluated.
To learn more about LEUKINE, please call LEUKLine, our
toll-free support line at 1-877-3LEUKINE (1-877-353-8546)
or visit us at www.leukine.com.
US.SAG.13.09.00109/13
US.SAG.13.08.00410/13
Please see additional Important Safety Information on previous page
©2013sanofi-aventis
sanofi-aventis
A SANOFI
COMPANYand full Prescribing Information available at www.leukine.com.
©2013
U.S.U.S.
LLC,LLC,
A SANOFI
COMPANY
References: 1. Buchsel PC, Forgey A, Grape FB, Hamann SS. Granulocytemacrophage colony-stimulating factor: current practice and novel approaches. Clin J Oncol Nurs. 2002;6:198-205.